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Module 1: Lesson 1
Understanding clinical trial budgets: revenue, cost, and the space between
Learn the structure of clinical trial budgets including per-patient payments, screen failure fees, procedure costs, and overhead calculations.
The number that changes everything
Your site is offered $4,500 per evaluable patient for a 12-month cardiovascular study. That sounds generous. The investigator is enthusiastic. The CRA mentions that other sites in the network are eager to participate. The number feels solid--$4,500 is real money.
Then you start reading the protocol.
Each patient requires a cardiac MRI at screening and at the 12-month visit. Your institution charges $1,800 per cardiac MRI. That is $3,600 of the $4,500 consumed by a single procedure at two timepoints. Monthly laboratory panels run $200 each--another $2,400 across 12 months. The protocol mandates 14 in-person visits, each requiring 90 minutes of coordinator time for data collection, specimen processing, and documentation. At fully loaded coordinator labor rates, that is roughly $2,100 in CRC time alone. Add the pharmacy's dispensing fee, the IRB's continuing review fee, and the institution's 26% indirect cost rate applied to modified total direct costs, and the $4,500 is not generous at all. It is a loss.
This is not a hypothetical scenario. It is the arithmetic that sites confront on every study they consider. And it is the arithmetic that most coordinators never learn--not because it is difficult, but because nobody teaches it. The prevailing assumption is that budgets are someone else's problem. The business office handles it. The site manager handles it. The principal investigator handles it.
But here is what I have observed over decades of working with clinical trial sites: the coordinator is the person whose daily decisions most directly affect whether a study is financially sustainable. Every procedure you schedule, every visit window you manage, every screening assessment you conduct is a line item on a budget. You are not responsible for negotiating the budget. But you are responsible for understanding it well enough to make informed operational decisions--and to contribute meaningfully when someone asks, "Can we actually conduct this study without losing money?"
What you will learn
By the end of this lesson, you will be able to: